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Treatment of venous disease – The innovators
ORIGINAl, ARTICLES From the American Venous Forum
Treatment o f venous d i s e a s e - T h e innovators James A. DeWeese, MD, Rochester, N.Y.
Advances in the management of any disease cannot be graphically represented by a straight line. If one plots advances versus time, there are a variety of ways that the resulting line might take shape. There could be an early period of gradual improvement in care followed by a sharp upswing. A period of time may then occur without any advances only to be followed by another sharp upswing. A period of negativism may follow with deterioration in care once again followed by a sharp upswing. Multiple possibilities for the shape of the line exist. The reason for the sharp upswings in this line, of course, is that something new has occurred. An innovation has been introduced. I have selected four innovations that I believe have been responsible for significant advances in the management of venous diseases during the twentieth century. There are others. These innovations may also fit the definition of l~nventions, but I selected innovations because that term more fairly suggests that previous discoveries also have been helpful to the responsible innovator. The four innovations that I have selected are the anticoagulant heparin, intraluminal partial venous interruption, balloon thrombectomy catheters, and pressure gradient stockings. THE ANTICOAGULANT HEPARIN
Venous thrombosis may occur in the superficial veins of the leg but is more commonly found in the From the Department of Surgery, The University of Rochester, Rochester. Presented as the Presidential Address at the Sixth Annual Meeting of the American Venous Forum, Wailea, Mani, Hawaii, Feb. 23-25, 1994. Reprint requests: James A. DeWeese, MD, Division of Cardiothoracic Surgery, University of Rochester Medical Center, 601 Elmwood Ave., Rochester, NY 14642-8410. Copyright © 1994 by The Society for Vascular Surgery and International Society for Cardiovascular Surgery, North American Chapter. J VASCSURG 1994;20:675-83. 0741-5214/94/$3.00 + 0 24/6/55878
deep veins as a result of trauma, stasis, or hypercoagulability. Early morbidity of deep venous thrombosis consists of pain, swelling, and the threat of pulmonary embolism. With a radioiodinated fibrinogen test, Kakkar 1 found thrombi in the soleal and deep veins of the calf in greater than 25% of patients after elective surgery. Without anticoagulation 10% of these patients will have propagation of the thrombi, and 3.4% will have pulmonary emboli. 2 Late morbidity of venous thrombosis consists of deep vein valvular insufficiency and ulceration. Gay3 recognized the relationship between venous thrombosis and subsequent ulceration in 1867. Homans in 19174 identified the postthrombotic valvular insufficiency as the cause of the ulcers. Bauer 6 noted the delayed occurrence of the ulcers after thrombosis with an incidence of 20% at 5 years, 52% at 10 years, and 79% at times later than 10 years. In the early 1900s the usual treatment for venous thrombosis, when recognized, was bed rest and elevation of the legs. There was no anticoagulation available to prevent propagation of the thrombus and pulmonary embolization. Charles H. Best, 6 in describing the discovery of heparin, stated, "In 1912 Doyan published a paper in which he describes an attempt to isolate and characterize an anticoagulant released by the injection of peptone in a dog. There are a number of other intriguing findings in the literature, but their significance could only be appreciated after the discovery of heparin." We come then to our first innovation, the anticoagulant heparin, and the innovator, Jay McLean (Fig. 1). 7,8 lohn T. (Jay) McLean was born in 1890 in California. His father died when Jay was 4 years old, and he was raised by his mother and stepfather. The family suffered the loss of their house and source of livelihood in the San Francisco earthquake and fire of 1906. Jay was able to be partially supported for 2 years of college at the University of California at Berkeley. His stepfather offered similar support for 4 years of medical school but only at the University 675
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Fig. 1. John T. (Jay) McLean. (Courtesy of W. G. Bigelow, MD, Toronto, Ontario, Canada)
of California Medical School. Jay was convinced, however, that Johns Hopkins offered him the best preparation for research, teaching, and an academic surgical career. He spent 15 months worldng at the Mojave gold mine and completed the third year of college required by Johns Hopkins, which was concurrently the first year of medical school. He worked another 15 months in the oil fields, and, although his application for Johns Hopkins had been rejected, he boarded a train for Baltimore in 1915. When settled he visited the medical school and introduced himself to the registrar and dean. Although they were surprised to see him, the next day the dean informed McLean there was an unexpected vacancy, and he was admitted to the school. Jay had used W. H. Howell's Textbook of Physiology at the University of California and was "fascinated with the subject and its research possibilities. "7 Having learned of his admission he immediately contacted Dr. Howell and requested the opportunity of spending a year in research in his laboratory. He told
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Howell "that I wanted a problem I could reasonably hope to finish and publish in one academic year entirely by myself.''7 Howell suggested that McLean study cephalin, a crude ether and alcohol extract of brain, which was a powerful thromboplastic agent that Howell used in blood clotting experiments. The cephalin precipitate decayed within 3 months. McLean found articles in the German literature, which described extracts of liver and heart resulting from a process similar to that for obtaining cephalin from the brain. They had been named heparphosphatide (from the liver) and courin (from the heart). McLean found that the resulting extracts did not accelerate the clotting of blood as well as cephalin, suggesting there was something else in the extracts other than cephalin. Fortuitously he made large batches of all of the extracts and periodically tested the thromboplastic activity of the extracts. He found that when exposed to air for about 3 months, all three extracts lost their thromboplastic activity. The miraculous finding was that the resulting extracts of liver had a strong anticoagulant action. Heparin was discovered! McLean accomplished this in 1915 to 1916 at the age of 24 and while still a medical student. McLean continued his pursuit of academic surgery. He graduated from medical school at Johns Hopkins in 1919, served on its surgical housestaff 1919 to 1921, and was a member of the surgical faculty and research laboratories at Johns Hopkins, University of California, and Ohio State University. He did not continue his*research on heparin. Howell and Holt ~° did pursue heparin and in 1928 published a detailed report of its chemical and physiologic reactions. It was Charles H. Best and his associates 6 who developed the purification of and production of heparin and established its experimental and clinical usage. He accomplished this in his laboratories at the University of Toronto, and also with the Connaught Laboratories with whom he "had been intimately concerned with the preparation of insulin and of liver extract. ''6 Much of the early clinical work was performed in the Department of Surgery at the University of Toronto, where Gordon F. Murray H made clinical trials beginning in April 1935. In 1941 he reported 700 patients treated with heparin. A large number were treated with prophylactic, and no pulmonary embolism occurred. Fortysix patients were treated after their first pulmonary embolus with no deaths and only two questionable pulmonary emboli. One hundred twenty-five patients were treated for phlebitis with no pulmonary emboli. H Craaford 12reported similar results in 1937. Additional controlled and comparative studies have
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confirmed that heparin therapy followed by coumarin derivatives is superior to no anticoagulation. 13,14 INTRALUMINAL PARTIAL VENOUS INTERRUPTION In most centers the current treatment for deep venous thrombosis is bed rest, elevation of the leg, intravenous heparin for 4 to 7 days, followed by oral warfarin (Coumadin) for 6 weeks to 6 months. Nonfatal and fatal emboli may still occur in 0.9% to 7.7% of patients treated with anticoagulants.iS A fatal pulmonary embolus is the most feared complication of venous thrombosis. Although warning signs may be present, 27% of 606 patients who died of pulmonary emboli had no warning signs or symptoms in an autopsy study reported by Coon and Coller. 16 Before the availability of heparin, ligation of the venous system was the only treatment available for prevention of pulmonary emboli. It remained available for patients with recurrent emboli while receiving heparin or when heparin was contraindicated. Femoral vein ligations were popular in the 1940s and 1950s but fell into disfavor because of reports of a 5% to 8% rate of fatal recurrent embolism. 17,18 Inferior vena caval ligation became the procedure of choice. Vena caval ligation has possible undesirable sequelae. Shock occurs in many patients because of the sudden decrease in venous return. Venous thrombosis progresses as a result of venous stasis. Recurrent emboli can still occur through collateral vessels. Postthrombotic chronic venous insufficiency occurs in as many as 35% of patients. Before 1958 there were reports of inducing temporary occlusion by ligation of the vena cava with absorbable catgut or removable metal clips in hopes of reducing the incidence of late postthrombotlc sequelae, but the problems of total occlusion still existed) 921 The time was set for our second innovation, intraluminal partial venous interruption, and its innovator, M. S. DeWeese (Fig. 2). Marion Spencer (Bill) DeWeese was born in Corydon, Indiana, in 1915. His family moved to Kent, Ohio when he was 8 years old. He grew up across the street from the campus of what became Kent State University. He completed his high school and college training on that campus. His father was a physician, and Bill knew at an early age that he wished to follow in his father's footsteps. He graduated from the University of Michigan Medical School in 1939 and entered the surgical residency program at University Hospital, which he completed in 1948, after having spent 1941 to 1945 in the United States Army Medical Corp.
Fig. 2. M. S. (Bill) DeWeese.
As a general surgeon with a special interest in vascular surgery, DeWeese had personally seen and treated patients after caval ligation in whom swelling, induration, and recurrent ulceration of their lower extremity had developed. In hopes of decreasing the morbidity after caval ligatlon, DeWeese 22 stated "We conceived that it might be feasible to construct an intraluminal filter of textile filaments within the vena cava. Such a filter could potentially block the transit of emboli without significantly disturbing the function or dynamics of the venous system." He selected silk for his filter because of Voorhees '23 observation "that a simple strand of silk suture traversing the chamber of the right ventricle of the heart of a dog became coated in a few months throughout its length by a glistening film free of macroscopic thrombi." No one, however, had ever tested the thrombogenicity of such materials in the venous system or explored the possibility of partially interrupting venous blood flow to prevent fatal pulmonary emboli. DeWeese 22 constructed intralurninal "harpgrid" filters in canine vena cavae by placing mattress stitches of 5-0 or 6-0 silk sutures on an atraumatic needle obliquely across the infrarenal vena cava. The sutures
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were carefully tied to prevent narrowing of the lumen. Control animals underwent autopsy at periodic intervals, and only one was found to have "minute 1 x 1 x 2 mm thrombi on the threads one day after operation but no other thrombi were seen and the threads were covered with intima by 1 - 3 weeks." Standard fibrinogen emboli introduced into the femoral veins of control animals caused death within 5 minutes, and autopsies revealed emboli in the pulmonary arteries. All animals with filters survived injection of thrombi into the femoral vein. Six of 30 animals at autopsy had small pulmonary emboli without detectible symptoms. Autopsies on animals in which clots were trapped by the filter demonstrated lysis or complete organization of the thrombi with recanalization in all animals. The clinical efficacy of the filter was later confirmed in 112 patients. 24None of the patients who had partial caval interruption died of pulmonary emboli. There was a 6.2% incidence of small nonfatal emboli. Since DeWeese first demonstrated that intraluminal partial venous interruption was feasible and effective, there have continued to bc significant advances in available devices and techniques of insertion, an example of a continuation in the sharp increase shown on the line of advances that follow an innovation. The next advance was the development of devices that could bc placed in the inferior vena cava through short venotomies in the femoral or jugular vein. The devices were single wires, umbrella-like plastics, or cone-shaped wire devices that were usually passed up the cava in removable sheaths. When the sheaths were removed, the devices sprung open. The Pate wire stretched the wall of the cava to produce a 3 mm slit. 2s The Eichelter umbrella-tipped catheter could be tied to the femoral vein and later removed. 26 The MobinUddin and Greenfield filters remained fixed to the wall of the cava by hooks. 27'28 The latest advance has been the percutaneous introduction of the filters. This has been made possible by the development of stainless steel Bird's Nest filters (Cook, Inc., Bloomington, Ind.) and titanium Greenfield filters, which can be housed in a 12F sheath dilator as compared with the previous 28F sheaths. 29,18 Ligation of the inferior vena cava was associated with an operative mortality rate of 14%, recurrent pulmonary embolism rates of 6%, and a fatal recurrent pulmonary embolism rate of 2%. is Recent experience with the Greenfield filter has resulted in operative mortality rates of 0%, recurrent pulmonary embolism rates of 3%, and recurrent fatal pulmonary embolism rates of less than 2%. is Partial vena caval interruption with extraluminal
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techniques has also flourished since DeWeese described his innovation. In 1959 Moretz et al?0 introduced a smooth U-shaped Teflon clip to narrow the cava. In 1964 Miles et al.31 used a clip with serrated edges that also compartmentalized the cava. In 1966 Adams and DeWeese modified the Miles clip by making one limb serrated and the other smooth, which facilitated the passage of the clip around the cava. In 1960 Spencer 33 plicated the cava by dividing it into compartments, with mattress sutures passed through the anterior and posterior wall of the cava, which divided it into channels 3 to 4 mm in diameter. Ravitch et al?4 accomplished compartmentalization with the mechanical stapler. All of these techniques have been successfully evaluated clinically and are still used by some surgeons, particularly when vena caval interruption is indicated prophylactically for a patient undergoing laparotomy. BALLOON T H R O M B E C T O M Y CATHETERS Massive iliofemoral venous thrombosis is associated with significant morbidity. Although the thrombosis may have ascended through the deep veins, it usually originates in the iliac veins or the greater saphenous vein. Phlebograms frequently reveal occlusion of the iliac vein with patent, normalappearing distal veins. Even with heparin therapy, decrease in pain and swelling is slow, venous gangrene may occur, fatal as opposed to nonfatal pulmonary embolism is more likely, and the postphlebitic syndrome is common. In hopes of minimizing these complications, Lawen in 1938 a5 performed the "ideal" thrombectomy through a femoral venotomy, followed by closure of the venotomy without ligation of the femoral veins as performed by others. Mahorner et al.a6 and Fontaine a7 reported series of such operations followed by heparin anticoagulation in 1957. The iliac thrombi were removed by abdominal pressure or by passage of tubes through the femoral venotomy, which were then attached to suction. The suction tubes were made of glass, metal, or flexible polyethylene, as These large catheters usually could not be passed into the vena cava because they met obstruction at the point where the iliac vein angulated medially and anteriorly over the sacrum, a9 They could not be passed distally into the femoral vein without destroying the venous valves. The distal clots were removed by massaging the leg or by elevating and compressing the legs with rubber elastic bandages. Good early results after thrombectomy were reported. 4° However, the occasional fatal intraoperative embolism, the inability to completely
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remove the thrombus with the methods available and the high rethrombosis rate discouraged most surgeons from performing thrombectomies. There was a need for an improved method for the extraction of venous thrombi. This brings us to our third innovation, the balloon thrombectomy catheter, and its innovator, Thomas J. Fogarty (Fig. 3).41 Thomas Fogarty was born in 1934 in Cincinnati, Ohio. His father died when Tom was very young, and it was necessary for him to work to help support the family. He delivered newspapers and mowed lawns and, while still in the eighth grade, was able to get a job in the central supply room of the Good Samaritan Hospital. While still in high school he became an operating room technician, where he first met Dr. John Cranley, a vascular surgeon. Cranley encouraged Tom and hired him to be his private technician. Tom at that time was not a good student and did not have his principal's strong recommendation for college. He was admitted to Xavier University on probation and quicldy learned how to study and got good grades. He continued to work part-time for Dr. Cranley throughout college. Early in his operating room experiences Tom noticed that embolectomies and thrombectomies were frequently unsuccessful. He thought about it for some time, and finally in his junior year of college he experimented with the construction of some balloon catheters out of some old ureteral catheters and thin-walled latex tubing. 41 Three years later, while taking a 1-year fellowship with Dr. Cranley and his group, he was finally able to fully evaluate clinically a new balloon catheter. He was still making the device himself. It consisted 0£ a semirigid plastic catheter to which a syringe could be attached. At the other end there were side holes in the catheter in an area where latex tubing was secured. Instillation of air or saline solution resulted in a ballooning out of the latex tubing. He first used his balloon catheter in the arteries of cadavers. He found that the tip of the catheters passed either between the wall of the artery and clots or through the softer portion of clots and that it was impossible to push the clots up the artery. Fogarty stated, "only with force exerted far beyond the usual surgical caution is one able to bring about dissection of plaques or arterial perforation in the cadaver. ''42 He used the balloon catheter to remove thrombus from the iliac vein and proximal superficial femoral vein through a common femoral venotomy in patients with iliofemoral venous thrombosis and phlegmasia cenalea dolens. 4a,44 Fogarty45 made further improvements in the performance ofiliofemoral venous thrombectomy by the passage of a balloon
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Fig. 3. Thomas Fogarty.
catheter up the uninvolved iliac vein for the temporary occlusion of the cava during thrombectomy. He was also able to pass the catheter distally by the manipulation of the catheter past valves with intermittent inflation and deflation of the balloon. Edema was absent in 17 of 20 patients, and phlebograms demonstrated patency of 10 of 13 iliofemoral veins after operation. 46 The availability of thrombolytic therapy has decreased the use ofthrombectomy for many patients with iliofemoral venous thrombosis. Venous thrombectomy by Fogarty balloon catheter technique is still, however, the treatment of choice for patients with phlegmasia cerulea dolens and threatened venous gangrene. The use of an arteriovenous fistula for the first few weeks after thrombectomy have improved the results. 47 PRESSURE G R A D I E N T STOCKINGS
Varicose veins have been recognized since antiquity, as recorded by ancient Greek sculptures. Hippocrates (460-3 77 BC) first recognized varicose veins as
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being associated with, if not the cause of, ulcers on the leg. 48 William Harvey described the circulation of blood in 1628. When he studied venous valves he appreciated their function of directing blood flow in one direction. It was not until the mid 1800s that J2 Gay recognized that ulcers of the leg were related to venous thrombosis and not necessarily to varicose veins. 3 It has only been during this century that the importance of postthrombotic venous valvular insufficiency (particularly in the deep and perforating veins) and the effect of gravity and the muscle pump on venous and pressures about the ankle as a cause of ulcers, has been understood. 4 The value of compression in the treatment of venous ulcers has long been recognized. Hippocrates described the use of compression bandages in the fourth century BC.48 Various materials and medicaments and methods of application have been used to the present time. Wiseman in 1676 compressed the leg with a leather laced stocking for the healing of ulcers. 48 The development of stockings made of elastic materials is a product of the twentieth century.
The elastic stockings available in the 1940s were of varying strength and weight. They werc made in only a few sizes. No attempt was made to vary the tension of the circumferential fibers of the stocking at various levels of the leg. A patient with a very thin ankle and thick calf could actually have higher compression in the calf than the ankle and exert a constricting effect that would impede venous return of blood. Most stockings did not effectively prevent ulceration and only rarely could be used in the treatment of ulcers. It was time for our fourth inn{ 'on, pressure gradient stockings, and their innovai 2onrad Jobst (Fig. 4). Conrad Jobst was boI ~ Erlanger, Germany in 1889. At an early age h s fascinated with machines and took a 5-year app iceship in a machine shop. He gained a reputatiol an engineer with a company based in Switzerland; came to the United States in 1911 at the age of: ~ construct machinery for the production of brus] In 1913 he became chief engineer for the Ames aner Brush Company of Toledo, Ohio. Conrac bst was an extremely intelligent and productive m and obtained more than 40 patents for sh making machines. Conrad Jobst had varicose veins t gradually increased in severity and prompted in on therapy at the Henry Ford Hospital in Det , Mich., in 1 9 3 0 . 49 All automobile accident occur in the sam{ year at which time both legs were over, ant swelling and pain of the left leg per, :l for mor{ than 6 months. An ulcer appeared Vlay 1936. which was treated with a pressure dl ng. Recur. rent ulcers and thrombophlebitis o{ red, whicl~ required pressure dressings, injectio, f the vein. and finally high and low saphenous v igations al the Henry Ford Hospital in 1947. Du periods ot disability, Conrad found relief of l )mfort by standing in a swimming pool In se: ing for a~ explanation for this relief, he made g~v_ use of his intelligence and scientific background. Diagrams ir~ handwriting indicate that he had a good understanding of normal venous physiology and the importance of the venous valves and muscular contraction within their fascial compartment in pumping blood through the deep veins against gravity when the leg is in vertical position. 49 He further reasoned that th{ hydrostatic pressure within the leg veins would b{ equaled by the hydrostatic pressure of the water wher standing in a pool. s° This would provide externa graded compression of both the superficial and dee[ veins of the leg, which could decrease "congestion' (venous blood volume) and provide strong circum. ferential support for the superficial veins so that "the
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elastic support works in unison with the natural muscle pump. ''49 Jobst set out to make an elastic stocking that would duplicate the hydrostatic pressure found in the swimming pool. The stocking would have to be a perfect fit. He accomplished this by making serial circumferenrial measurements of the leg, which were used to make a pattern from which the elastic material could be cut for individualized stockings. He developed a partially elastic "bobinet" woven fabric that had both uniform and predictable stretching and contracting abilities. Graded pressures exerted by the stockings were obtained by progressively reducing the circumference of the stocking from the top of the stocking to the ankle by the percentage necessary. The first stockings were made by hand by Jobst and enabled him to enjoy rapid and continued relief of his own disability. Beninson51 described the early success of the use of pressure gradient stockings in the management of difficult cases of venous ulcers and edema. The positive benefits of graded compression elastic support have been confirmed by several physiologic studies. The velocity of flow in the femoral veins has been studied in normal resting limbs at various graduated external pressures by Lawrence and Kakkar. s2 They found up to 75% increase in deep venous flow with optimal ankle compressions of 18 mm Hg and calf compression of 14 mm Hg with knee-high stockings. Johnson and others have made similar observations. 5a Their studies have objectively demonstrated that properly constructed graded compression stockings increase venous velocity presumably caused by a reduction in circulating venous blood volume and supports the use of these stockings for prophylaxis against thromboembolism. Ambulatory foot venous pressure studies were performed on postphlebitic and normal limbs by O'Donnell and associates, 54 They observed wide swings in amplitude of the pressure tracings during exercise in postphlebitic limbs without stockings with resultant markedly elevated peak pressures. The amplitude of the venous pressure tracings could be normalized with noncustom-made elastic stockings. Homer 5~ performed similar studies on 22 extremities with deep venous valvular insufficiency. They found four patients with small ankles and large calves in which the noncustom-made "graduated pressure" elastic stockings did not have a pressure gradient between their ankle and calf. Stockings were custom-made for them. Pressu;e gradients between the ankle and calf produced by the stockings were then measured for all 22 extremities. They found
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greater decreases in the venous pressure after exercise with stockings on in all but two patients with known deep venous obstruction. Of most significance is that "the greater the compression gradient between the ankle and calf produced by the stocking, the lower the ambulatory venous pressures." Somerville and associates 56 measured ambulatory venous pressures on patients with varicose veins after wearing elastic stockings in which significant pressure gradients between the ankle and the calf were confirmed. The pressures were measured before and 1 and 2 months after wearing the stocking. The stocking was discarded, and then the pressure was measured 1 and 5 months later. The ambulatory venous pressures progressively and significantly fell, and symptoms improved during the 2 months that elastic support was worn and then gradually returned to the pretesting values during the 5 months that no elastic support was used. A significantly positive correlation was found between symptoms and venous ambulatory pressures. The advantage of decreased ambulatory venous pressures for patients with venous insufficiency was emphasized by Shull and associatesS He found that the incidence of ulceration with ambulatory venous pressures greater than 60 mm Hg was 66%, with 40 to 60 mm Hg pressure the incidence was 26%, and with less than 40 mm Hg pressure it was 0. Limb volume, sodium 24 clearance, and calf circumferences have also been used to evaluate the effectiveness of graded compression elastic stockings. Jones and associates s8 measured foot volumes and 24Na clearance studies from the subcutaneous tissue at the ankle before and after exercise pretesting and 3 weeks after wearing elastic stockings. Patients were randomly assigned to wear elastic stockings that exerted ankle compression of 30, 30 to 40, and 40 to 50 mm Hg. All patients wore the three different compression stockings for 3 weeks, with 6 weeks without stockings between the test periods. Normal limbs demonstrated no significant changes in foot volume or 24Na clearance with the use of stockings at rest or after exercise. Limbs with varicose veins demonstrated no significant changes in foot volumes during testing. However, 24Na clearance was significantly improved at rest and almost significantly improved after exercise from using the 30 to 40 mm Hg compression stockings. Postphlebitic limbs demonstrated significant decreases in foot volume and increases in 24Na clearance after the use of the 30 to 40 mm Hg and 40 to 50 mm Hg compression stockings. Pierson, Swallow, and J o h n s o n 59 studied the changes in lower leg volumes and calf circumferences of 30 control subjects and 73 patients with
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s y m p t o m a t i c venous a n d l y m p h a t i c abnormalities w h o w o r e g r a d e d c o m p r e s s i o n elastic stockings that h a d 2 4 m m H g pressure c o m p r e s s i o n at the ankle for 1 week. I n n o r m a l limbs there was significant decrease in v o l u m e . I n patients w i t h s y m p t o m s there was a significant decrease in v o l u m e , circumference, a n d s y m p t o m s w i t h use o f the stockings. These p h y s i o l o g i c studies s u p p o r t the hypothesis t h a t p r o p e r l y fitted g r a d e d c o m p r e s s i o n elastic stockings encase the veins in a s e m i r i g i d elastic envelope. This envelope decreases the v o l u m e o f the superficial v e n o u s system, decreases the d i a m e t e r o f the dilated veins thus r e s t o r i n g valvular c o m p e t e n c e , o p p o s e s the reflux o f b l o o d t h r o u g h i n c o m p e t e n t perforators i n t o the superficial veins, a n d p o s s i b l y enhances c o m p r e s s i o n a n d e m p t y i n g o f d e e p veins d u r i n g calf muscle contraction, s6 These studies also s u p p o r t the logic t h a t C o n r a d J o b s t expressed in explaining the beneficial effects o f h y d r o s t a t i c pressure o n his venous stasis ulcers, w h i c h l e d to the d e v e l o p m e n t o f g r a d e d c o m p r e s s i o n elastic stockings. I agree w i t h the s t a t e m e n t o f Dr. J o h n Bergan t h a t " T h e single advance t h a t has h a d the m o s t i m p a c t o n the t r e a t m e n t o f v e n o u s stasis disease has been the d e v e l o p m e n t o f v e n o u s pressure g r a d i e n t s u p p o r t . ''49 REFERENCES
1. Kakkar V. the Diagnosis of deep vein thrombosis using the 125~ fibrinogen test. Surgery 1972;104:152-6. 2. Soils MM, Ranval TV, Barnes RW, et al. Is anticoagulation indicated for asymptomatic postoperative calf vein thrombosis? J VASCSUnG 1992;16:414-9. 3. Gay J. On varicose diseases of the lower extremities. In: The Lettsomian Lectures of 1867. London: Churchill, 1868. 4. Homans J. The etiology of treatment of varicose ulcer of the leg. Surg Gynecol Obstet 1917;24:300-8. 5. Bauer G. A roentgenologicai and clinical study of the sequels of thrombus. Acta Chir Scand 1942;86 (Suppl 75): 1- 11. 6. Best CH. Preparation ofheparin and its use in the first clinical cases. Circulation 1959;19:79-86. 7. Mclean 1- The discovery of heparin. Circulation 1959;19: 75-8. 8. Bigelow WG. Discovery of heparin. In: Bigelow WG, ed. Mysterious heparin. Toronto-Montreal: McGraw-Hill Ryerson, 1990:7-16. 9. McLean J. The thromboplastic action of cephalin. Am J Physiol 1916;41:250-8. 10. Howell WH, Holt E. The purification of heparin and its chemical and physiologic reactions. Bull Johns Hopkins Hosp 1928;42:199-207. 11. Murray G. Heparin in thrombosis and blood vessel surgery. Surg Gynecol Obstet 1941;72:340-4. 12. Craaford C. Preliminary report on postoperative treatment with heparin as a preventive of thrombosis. Acta Chir Scandiav 1937;79:162-9. 13. Barritt DW, Jordan SC. Anticoagulant drugs in the treatment of pulmonary embolism: a controlled trial. Lancet 1960;1: 309-11.
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14. Coon WW, Willis PW, III, Symons MJ. Assessment of anticoagulant treatment of venous thromboembolism. Ann Surg 1969;170:559-68. 15. DeWeese JA. Venous and lymphatic diseases. In: Schwartz SI, ed. Principles of Surgery. 4th ed. New York: Mcgraw-Hill, 1984:981. 16. Coon WW, Coller FA. Clmicopathologic correlation in thromboembolism. Surg Gynecol Obstet 1959;109:259-67. 17. Homans J. Deep quiet venous thrombosis in the lower limb. Surg Gynecol Obstet 1944;79:70-82. 18. Greenfield LJ. Evolution of venous interruption for pulmonary thromboembolism. Arch Surg 1992;127:622-6. 19. Moretz WH, Naisbitt PF, Stevenson GP. Experimental studies on temporary occlusion of the inferior vena cava. Surgery 1954;36:384-98. 20. Dale WA, Pualwan F, Bauer FM. Ligation of the inferior vena cava with absorbable gut. Surg Gynecol Obstet 1956;102: 517-30. 21. Stretuer MA, Paine JR. Temporary occlusion of the inferior vena cava suggested as a means of treatment in thromboembolism requiring cava ligation. Surgery 1953;94:20-7. 22. DeWeese MS, Hunter DC Jr. Avena cava filter for the prevention of pulmonary emboli. Bulletin De La Societe Internationale De Chirurgie 1958; 1:1-9. 23. Voorhees AB, Jaretzki A III, Blakemore AH. The use of tubes constructed from Vinyon "N" cloth in bridging arterial defects. Ann Surg 1952;135:332-6. 24. Deweese MS, Kraft RO, Nichols WK et al. Fifteen-year clinical experience with vena cava filter. Ann Surg 1973;178: 247-57. 25. Pate JW, Melvin D, Cheek RC. A new form of vena caval interruption. Ann Surg 1969;169:873-80. 26. Eichelter P, Schenk WG Jr. Prophylaxis of pulmonary embolism. Arch Surg 1968;97:348-64. 27. Mobin-Uddin K, McLean R, June JR. A new catheter technique of interruption of inferior vena cava for prevention of pulmonary embolism. Am Surg 1969;35:889-94. 28. Greenfield LJ, McCurdy JR, Brown PP et al. A new intracaval filter permitting continued flow and resolution of emboli. Surgery 1973;73:599-606. 29. Roehm JOF Jr, Johnsrude IS, Barth MH, et aL The birds nest inferior vena caval filter: progress report. Radiology 1988; 168:745-9. 30. Moretz WH, Rhode CM, Shephard MH. Prevention of pulmonary emboli by partial occlusion of the inferior vena cava. Am Surg 1959;25:617-23. 31. Miles RM, Chapell F, Rennet O. A partially occluding vena caval clip for prevention of pulmonary embolism. Am Surg 1964;30:40-6. 32. Adams JT, DeWeese JA. Partial interruption of the inferior vena cava with a new plastic clip. Surg Gynecol Obstet 1966;123:1087-8. 33. Spencer FC. An experimental evaluation ofpartitioning of the inferior vena cava to prevent pulmonary embolism. Surg Forum 1960;10:680-2. 34. Ravitch MM, Snodgrass E, McEnany T, et al. A compartmentalization of the vena cava with the mechanical stapler. Surg Gynecol Obstet 1966;122:561-4. 35. Lawen A. Weltere Erfahrungen uber operative thrombenentfernung bei venenthrombose. Arch Klin Chir 1938;193: 723. 36. Mahorner H, Castleberry JW, Coleman WD. Attempts to restore fianction in major veins which are the site of massive thrombosis. Ann Surg 1957;146:510-8.
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37. Fontaine R. Remarks concerning venous thrombosis and its sequelae. Surgery 1957;41:6-11. 38. Dale WA. Endovascular suction catheters. J Thorac Cardiovasc Surg 1962;44:557-8. 39. DeWeese JA, Jones TI, Lyon J, et al. Evaluation of thrombectomy in the management of iliofemoral venous thrombosis. Surgery 1960;47:140-59. 40. DeWeese JA. Thrombectomy for acute iliofemoral venous thrombosis. J Cardiov Surg 1964;5:703-12. 41. Friedman SG. The Fogarty catheter. In: Friedman SG, ed. A history of vascular surgery. Mount Kisco, NY: Futura, 1989:198-202. 42. Fogarty TJ, Cranley JJ, Kranse RJ, et al. A method for extraction of arterial emboli and thrombi. Surg Gynecol Obstet 1963;116:241-4. 43. Fogarty TJ, Cranley JJ, Krause RJ, et al. Surgical management of phlegmasia cerulea dolens. Arch Surg 1963;86:256-63. 44. Fogarty TH, Krippaehne WW. Catheter technique for venous thrombectomy. Surg Gynecol Obstet 1965;121:362-3. 45. Fogarty TJ, Hallen RW. Temporary caval occlusion during venous thrombectomy. Surg Gynecol Obstet 1966; 1269-72. 46. Fogarty TJ, Dennis D, Krippaehne WW. Surgical management of iliofemoral venous thrombosis. Am J Surg 1966; 112:211-7. 47. Neglen P, A1-Hassan HI(h, Endrys Jet al. Iliofemoral venous thrombectomy followed by percutaneous closure of the temporary arteriovenous fistula. Surgery 1991;110:493-9. 48. Arming ST. The historical aspects. In the pathology and surgery of the veins of the lower limb. Chapt II. Edinburgh and London England: E & S Livingstone Ltd. 1956;6:27. 49. Bergan JJ. Conrad Jobst and the development of pressure gradient therapy for venous disease. In: Bergan JJ, Yao JST,
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51. 52.
53. 54.
55.
56.
57.
58.
59.
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eds. Surgery of the veins. New York: Grtme& Stratton; 1985:529-40. Gauer OH. Otto Gauer Looks Back. In: Schael F, ed. Conrad Jobst, M.E. Columbus, Ohio: Media Words & Pictures, Inc.; 1979:30-9. Beninson J. Six years ofpressure-gradient therapy. Angiology 1961;12:38-45. Lawrence D, Kakkar W . Graduated, static, external compression of the lower limb: a physiological assessment. Br J Surg 1980;67:119-21. Johnson G Jr., Kupper C, Farrar DJ, et al. Graded compression stockings. Arch Surg 1982;117:69-72. O'Donnell TF Jr, Rosenthal DA, Callow AD, et al. Effect of elastic stockings compression on venous hemodynamics in postphlebitic limbs. JAMA 1979;242:2766-8. Homer J, Fernandes E, Fernandes J, Nicolaides AN. Value of graduated compression stockings in deep venous insufficiency. Br Med J 1980;22:820-1. Somerville JJF, Brow GO, Byrne PJ, et al. The effect of elastic stockings on superficial venous pressures in patients with venous insufficiency. Br J Surg 1974;61:979-81. Shull KC, Nicolaldes AN, Fernandes e Fernandes J, et al. Significance of popliteal reflux in relation to ambulatory venous pressure and ulceration. Arch Surg 1979;114:1304-6. Jones NAG, Webb PJ, Rees RI, et al. A physiological study of elastic compression stockings in venous disorders of the leg. Br J Surg 1980;67:569-72. Pierson S, Pierson D, Swallow R, et al. Efficacy of graded elastic compression in the lower leg. JAMA 1983;249:242-3.
Submitted March 2, 1994; accepted March 9, 1994.
Treatment o f venous d i s e a s e - T h e innovators James A. DeWeese, MD, Rochester, N.Y.
Advances in the management of any disease cannot be graphically represented by a straight line. If one plots advances versus time, there are a variety of ways that the resulting line might take shape. There could be an early period of gradual improvement in care followed by a sharp upswing. A period of time may then occur without any advances only to be followed by another sharp upswing. A period of negativism may follow with deterioration in care once again followed by a sharp upswing. Multiple possibilities for the shape of the line exist. The reason for the sharp upswings in this line, of course, is that something new has occurred. An innovation has been introduced. I have selected four innovations that I believe have been responsible for significant advances in the management of venous diseases during the twentieth century. There are others. These innovations may also fit the definition of l~nventions, but I selected innovations because that term more fairly suggests that previous discoveries also have been helpful to the responsible innovator. The four innovations that I have selected are the anticoagulant heparin, intraluminal partial venous interruption, balloon thrombectomy catheters, and pressure gradient stockings. THE ANTICOAGULANT HEPARIN
Venous thrombosis may occur in the superficial veins of the leg but is more commonly found in the From the Department of Surgery, The University of Rochester, Rochester. Presented as the Presidential Address at the Sixth Annual Meeting of the American Venous Forum, Wailea, Mani, Hawaii, Feb. 23-25, 1994. Reprint requests: James A. DeWeese, MD, Division of Cardiothoracic Surgery, University of Rochester Medical Center, 601 Elmwood Ave., Rochester, NY 14642-8410. Copyright © 1994 by The Society for Vascular Surgery and International Society for Cardiovascular Surgery, North American Chapter. J VASCSURG 1994;20:675-83. 0741-5214/94/$3.00 + 0 24/6/55878
deep veins as a result of trauma, stasis, or hypercoagulability. Early morbidity of deep venous thrombosis consists of pain, swelling, and the threat of pulmonary embolism. With a radioiodinated fibrinogen test, Kakkar 1 found thrombi in the soleal and deep veins of the calf in greater than 25% of patients after elective surgery. Without anticoagulation 10% of these patients will have propagation of the thrombi, and 3.4% will have pulmonary emboli. 2 Late morbidity of venous thrombosis consists of deep vein valvular insufficiency and ulceration. Gay3 recognized the relationship between venous thrombosis and subsequent ulceration in 1867. Homans in 19174 identified the postthrombotic valvular insufficiency as the cause of the ulcers. Bauer 6 noted the delayed occurrence of the ulcers after thrombosis with an incidence of 20% at 5 years, 52% at 10 years, and 79% at times later than 10 years. In the early 1900s the usual treatment for venous thrombosis, when recognized, was bed rest and elevation of the legs. There was no anticoagulation available to prevent propagation of the thrombus and pulmonary embolization. Charles H. Best, 6 in describing the discovery of heparin, stated, "In 1912 Doyan published a paper in which he describes an attempt to isolate and characterize an anticoagulant released by the injection of peptone in a dog. There are a number of other intriguing findings in the literature, but their significance could only be appreciated after the discovery of heparin." We come then to our first innovation, the anticoagulant heparin, and the innovator, Jay McLean (Fig. 1). 7,8 lohn T. (Jay) McLean was born in 1890 in California. His father died when Jay was 4 years old, and he was raised by his mother and stepfather. The family suffered the loss of their house and source of livelihood in the San Francisco earthquake and fire of 1906. Jay was able to be partially supported for 2 years of college at the University of California at Berkeley. His stepfather offered similar support for 4 years of medical school but only at the University 675
676 DeWeese
Fig. 1. John T. (Jay) McLean. (Courtesy of W. G. Bigelow, MD, Toronto, Ontario, Canada)
of California Medical School. Jay was convinced, however, that Johns Hopkins offered him the best preparation for research, teaching, and an academic surgical career. He spent 15 months worldng at the Mojave gold mine and completed the third year of college required by Johns Hopkins, which was concurrently the first year of medical school. He worked another 15 months in the oil fields, and, although his application for Johns Hopkins had been rejected, he boarded a train for Baltimore in 1915. When settled he visited the medical school and introduced himself to the registrar and dean. Although they were surprised to see him, the next day the dean informed McLean there was an unexpected vacancy, and he was admitted to the school. Jay had used W. H. Howell's Textbook of Physiology at the University of California and was "fascinated with the subject and its research possibilities. "7 Having learned of his admission he immediately contacted Dr. Howell and requested the opportunity of spending a year in research in his laboratory. He told
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Howell "that I wanted a problem I could reasonably hope to finish and publish in one academic year entirely by myself.''7 Howell suggested that McLean study cephalin, a crude ether and alcohol extract of brain, which was a powerful thromboplastic agent that Howell used in blood clotting experiments. The cephalin precipitate decayed within 3 months. McLean found articles in the German literature, which described extracts of liver and heart resulting from a process similar to that for obtaining cephalin from the brain. They had been named heparphosphatide (from the liver) and courin (from the heart). McLean found that the resulting extracts did not accelerate the clotting of blood as well as cephalin, suggesting there was something else in the extracts other than cephalin. Fortuitously he made large batches of all of the extracts and periodically tested the thromboplastic activity of the extracts. He found that when exposed to air for about 3 months, all three extracts lost their thromboplastic activity. The miraculous finding was that the resulting extracts of liver had a strong anticoagulant action. Heparin was discovered! McLean accomplished this in 1915 to 1916 at the age of 24 and while still a medical student. McLean continued his pursuit of academic surgery. He graduated from medical school at Johns Hopkins in 1919, served on its surgical housestaff 1919 to 1921, and was a member of the surgical faculty and research laboratories at Johns Hopkins, University of California, and Ohio State University. He did not continue his*research on heparin. Howell and Holt ~° did pursue heparin and in 1928 published a detailed report of its chemical and physiologic reactions. It was Charles H. Best and his associates 6 who developed the purification of and production of heparin and established its experimental and clinical usage. He accomplished this in his laboratories at the University of Toronto, and also with the Connaught Laboratories with whom he "had been intimately concerned with the preparation of insulin and of liver extract. ''6 Much of the early clinical work was performed in the Department of Surgery at the University of Toronto, where Gordon F. Murray H made clinical trials beginning in April 1935. In 1941 he reported 700 patients treated with heparin. A large number were treated with prophylactic, and no pulmonary embolism occurred. Fortysix patients were treated after their first pulmonary embolus with no deaths and only two questionable pulmonary emboli. One hundred twenty-five patients were treated for phlebitis with no pulmonary emboli. H Craaford 12reported similar results in 1937. Additional controlled and comparative studies have
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confirmed that heparin therapy followed by coumarin derivatives is superior to no anticoagulation. 13,14 INTRALUMINAL PARTIAL VENOUS INTERRUPTION In most centers the current treatment for deep venous thrombosis is bed rest, elevation of the leg, intravenous heparin for 4 to 7 days, followed by oral warfarin (Coumadin) for 6 weeks to 6 months. Nonfatal and fatal emboli may still occur in 0.9% to 7.7% of patients treated with anticoagulants.iS A fatal pulmonary embolus is the most feared complication of venous thrombosis. Although warning signs may be present, 27% of 606 patients who died of pulmonary emboli had no warning signs or symptoms in an autopsy study reported by Coon and Coller. 16 Before the availability of heparin, ligation of the venous system was the only treatment available for prevention of pulmonary emboli. It remained available for patients with recurrent emboli while receiving heparin or when heparin was contraindicated. Femoral vein ligations were popular in the 1940s and 1950s but fell into disfavor because of reports of a 5% to 8% rate of fatal recurrent embolism. 17,18 Inferior vena caval ligation became the procedure of choice. Vena caval ligation has possible undesirable sequelae. Shock occurs in many patients because of the sudden decrease in venous return. Venous thrombosis progresses as a result of venous stasis. Recurrent emboli can still occur through collateral vessels. Postthrombotic chronic venous insufficiency occurs in as many as 35% of patients. Before 1958 there were reports of inducing temporary occlusion by ligation of the vena cava with absorbable catgut or removable metal clips in hopes of reducing the incidence of late postthrombotlc sequelae, but the problems of total occlusion still existed) 921 The time was set for our second innovation, intraluminal partial venous interruption, and its innovator, M. S. DeWeese (Fig. 2). Marion Spencer (Bill) DeWeese was born in Corydon, Indiana, in 1915. His family moved to Kent, Ohio when he was 8 years old. He grew up across the street from the campus of what became Kent State University. He completed his high school and college training on that campus. His father was a physician, and Bill knew at an early age that he wished to follow in his father's footsteps. He graduated from the University of Michigan Medical School in 1939 and entered the surgical residency program at University Hospital, which he completed in 1948, after having spent 1941 to 1945 in the United States Army Medical Corp.
Fig. 2. M. S. (Bill) DeWeese.
As a general surgeon with a special interest in vascular surgery, DeWeese had personally seen and treated patients after caval ligation in whom swelling, induration, and recurrent ulceration of their lower extremity had developed. In hopes of decreasing the morbidity after caval ligatlon, DeWeese 22 stated "We conceived that it might be feasible to construct an intraluminal filter of textile filaments within the vena cava. Such a filter could potentially block the transit of emboli without significantly disturbing the function or dynamics of the venous system." He selected silk for his filter because of Voorhees '23 observation "that a simple strand of silk suture traversing the chamber of the right ventricle of the heart of a dog became coated in a few months throughout its length by a glistening film free of macroscopic thrombi." No one, however, had ever tested the thrombogenicity of such materials in the venous system or explored the possibility of partially interrupting venous blood flow to prevent fatal pulmonary emboli. DeWeese 22 constructed intralurninal "harpgrid" filters in canine vena cavae by placing mattress stitches of 5-0 or 6-0 silk sutures on an atraumatic needle obliquely across the infrarenal vena cava. The sutures
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were carefully tied to prevent narrowing of the lumen. Control animals underwent autopsy at periodic intervals, and only one was found to have "minute 1 x 1 x 2 mm thrombi on the threads one day after operation but no other thrombi were seen and the threads were covered with intima by 1 - 3 weeks." Standard fibrinogen emboli introduced into the femoral veins of control animals caused death within 5 minutes, and autopsies revealed emboli in the pulmonary arteries. All animals with filters survived injection of thrombi into the femoral vein. Six of 30 animals at autopsy had small pulmonary emboli without detectible symptoms. Autopsies on animals in which clots were trapped by the filter demonstrated lysis or complete organization of the thrombi with recanalization in all animals. The clinical efficacy of the filter was later confirmed in 112 patients. 24None of the patients who had partial caval interruption died of pulmonary emboli. There was a 6.2% incidence of small nonfatal emboli. Since DeWeese first demonstrated that intraluminal partial venous interruption was feasible and effective, there have continued to bc significant advances in available devices and techniques of insertion, an example of a continuation in the sharp increase shown on the line of advances that follow an innovation. The next advance was the development of devices that could bc placed in the inferior vena cava through short venotomies in the femoral or jugular vein. The devices were single wires, umbrella-like plastics, or cone-shaped wire devices that were usually passed up the cava in removable sheaths. When the sheaths were removed, the devices sprung open. The Pate wire stretched the wall of the cava to produce a 3 mm slit. 2s The Eichelter umbrella-tipped catheter could be tied to the femoral vein and later removed. 26 The MobinUddin and Greenfield filters remained fixed to the wall of the cava by hooks. 27'28 The latest advance has been the percutaneous introduction of the filters. This has been made possible by the development of stainless steel Bird's Nest filters (Cook, Inc., Bloomington, Ind.) and titanium Greenfield filters, which can be housed in a 12F sheath dilator as compared with the previous 28F sheaths. 29,18 Ligation of the inferior vena cava was associated with an operative mortality rate of 14%, recurrent pulmonary embolism rates of 6%, and a fatal recurrent pulmonary embolism rate of 2%. is Recent experience with the Greenfield filter has resulted in operative mortality rates of 0%, recurrent pulmonary embolism rates of 3%, and recurrent fatal pulmonary embolism rates of less than 2%. is Partial vena caval interruption with extraluminal
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techniques has also flourished since DeWeese described his innovation. In 1959 Moretz et al?0 introduced a smooth U-shaped Teflon clip to narrow the cava. In 1964 Miles et al.31 used a clip with serrated edges that also compartmentalized the cava. In 1966 Adams and DeWeese modified the Miles clip by making one limb serrated and the other smooth, which facilitated the passage of the clip around the cava. In 1960 Spencer 33 plicated the cava by dividing it into compartments, with mattress sutures passed through the anterior and posterior wall of the cava, which divided it into channels 3 to 4 mm in diameter. Ravitch et al?4 accomplished compartmentalization with the mechanical stapler. All of these techniques have been successfully evaluated clinically and are still used by some surgeons, particularly when vena caval interruption is indicated prophylactically for a patient undergoing laparotomy. BALLOON T H R O M B E C T O M Y CATHETERS Massive iliofemoral venous thrombosis is associated with significant morbidity. Although the thrombosis may have ascended through the deep veins, it usually originates in the iliac veins or the greater saphenous vein. Phlebograms frequently reveal occlusion of the iliac vein with patent, normalappearing distal veins. Even with heparin therapy, decrease in pain and swelling is slow, venous gangrene may occur, fatal as opposed to nonfatal pulmonary embolism is more likely, and the postphlebitic syndrome is common. In hopes of minimizing these complications, Lawen in 1938 a5 performed the "ideal" thrombectomy through a femoral venotomy, followed by closure of the venotomy without ligation of the femoral veins as performed by others. Mahorner et al.a6 and Fontaine a7 reported series of such operations followed by heparin anticoagulation in 1957. The iliac thrombi were removed by abdominal pressure or by passage of tubes through the femoral venotomy, which were then attached to suction. The suction tubes were made of glass, metal, or flexible polyethylene, as These large catheters usually could not be passed into the vena cava because they met obstruction at the point where the iliac vein angulated medially and anteriorly over the sacrum, a9 They could not be passed distally into the femoral vein without destroying the venous valves. The distal clots were removed by massaging the leg or by elevating and compressing the legs with rubber elastic bandages. Good early results after thrombectomy were reported. 4° However, the occasional fatal intraoperative embolism, the inability to completely
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remove the thrombus with the methods available and the high rethrombosis rate discouraged most surgeons from performing thrombectomies. There was a need for an improved method for the extraction of venous thrombi. This brings us to our third innovation, the balloon thrombectomy catheter, and its innovator, Thomas J. Fogarty (Fig. 3).41 Thomas Fogarty was born in 1934 in Cincinnati, Ohio. His father died when Tom was very young, and it was necessary for him to work to help support the family. He delivered newspapers and mowed lawns and, while still in the eighth grade, was able to get a job in the central supply room of the Good Samaritan Hospital. While still in high school he became an operating room technician, where he first met Dr. John Cranley, a vascular surgeon. Cranley encouraged Tom and hired him to be his private technician. Tom at that time was not a good student and did not have his principal's strong recommendation for college. He was admitted to Xavier University on probation and quicldy learned how to study and got good grades. He continued to work part-time for Dr. Cranley throughout college. Early in his operating room experiences Tom noticed that embolectomies and thrombectomies were frequently unsuccessful. He thought about it for some time, and finally in his junior year of college he experimented with the construction of some balloon catheters out of some old ureteral catheters and thin-walled latex tubing. 41 Three years later, while taking a 1-year fellowship with Dr. Cranley and his group, he was finally able to fully evaluate clinically a new balloon catheter. He was still making the device himself. It consisted 0£ a semirigid plastic catheter to which a syringe could be attached. At the other end there were side holes in the catheter in an area where latex tubing was secured. Instillation of air or saline solution resulted in a ballooning out of the latex tubing. He first used his balloon catheter in the arteries of cadavers. He found that the tip of the catheters passed either between the wall of the artery and clots or through the softer portion of clots and that it was impossible to push the clots up the artery. Fogarty stated, "only with force exerted far beyond the usual surgical caution is one able to bring about dissection of plaques or arterial perforation in the cadaver. ''42 He used the balloon catheter to remove thrombus from the iliac vein and proximal superficial femoral vein through a common femoral venotomy in patients with iliofemoral venous thrombosis and phlegmasia cenalea dolens. 4a,44 Fogarty45 made further improvements in the performance ofiliofemoral venous thrombectomy by the passage of a balloon
DeWeese 679
Fig. 3. Thomas Fogarty.
catheter up the uninvolved iliac vein for the temporary occlusion of the cava during thrombectomy. He was also able to pass the catheter distally by the manipulation of the catheter past valves with intermittent inflation and deflation of the balloon. Edema was absent in 17 of 20 patients, and phlebograms demonstrated patency of 10 of 13 iliofemoral veins after operation. 46 The availability of thrombolytic therapy has decreased the use ofthrombectomy for many patients with iliofemoral venous thrombosis. Venous thrombectomy by Fogarty balloon catheter technique is still, however, the treatment of choice for patients with phlegmasia cerulea dolens and threatened venous gangrene. The use of an arteriovenous fistula for the first few weeks after thrombectomy have improved the results. 47 PRESSURE G R A D I E N T STOCKINGS
Varicose veins have been recognized since antiquity, as recorded by ancient Greek sculptures. Hippocrates (460-3 77 BC) first recognized varicose veins as
680
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::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::~:::::::::~:::::U~::::::::+~+::~:X~::~::~~
~
A::u:~/::::::~:::;:::::::::::::::::::::::::::::::::::
Fig. 4. Conrad Jobst.
being associated with, if not the cause of, ulcers on the leg. 48 William Harvey described the circulation of blood in 1628. When he studied venous valves he appreciated their function of directing blood flow in one direction. It was not until the mid 1800s that J2 Gay recognized that ulcers of the leg were related to venous thrombosis and not necessarily to varicose veins. 3 It has only been during this century that the importance of postthrombotic venous valvular insufficiency (particularly in the deep and perforating veins) and the effect of gravity and the muscle pump on venous and pressures about the ankle as a cause of ulcers, has been understood. 4 The value of compression in the treatment of venous ulcers has long been recognized. Hippocrates described the use of compression bandages in the fourth century BC.48 Various materials and medicaments and methods of application have been used to the present time. Wiseman in 1676 compressed the leg with a leather laced stocking for the healing of ulcers. 48 The development of stockings made of elastic materials is a product of the twentieth century.
The elastic stockings available in the 1940s were of varying strength and weight. They werc made in only a few sizes. No attempt was made to vary the tension of the circumferential fibers of the stocking at various levels of the leg. A patient with a very thin ankle and thick calf could actually have higher compression in the calf than the ankle and exert a constricting effect that would impede venous return of blood. Most stockings did not effectively prevent ulceration and only rarely could be used in the treatment of ulcers. It was time for our fourth inn{ 'on, pressure gradient stockings, and their innovai 2onrad Jobst (Fig. 4). Conrad Jobst was boI ~ Erlanger, Germany in 1889. At an early age h s fascinated with machines and took a 5-year app iceship in a machine shop. He gained a reputatiol an engineer with a company based in Switzerland; came to the United States in 1911 at the age of: ~ construct machinery for the production of brus] In 1913 he became chief engineer for the Ames aner Brush Company of Toledo, Ohio. Conrac bst was an extremely intelligent and productive m and obtained more than 40 patents for sh making machines. Conrad Jobst had varicose veins t gradually increased in severity and prompted in on therapy at the Henry Ford Hospital in Det , Mich., in 1 9 3 0 . 49 All automobile accident occur in the sam{ year at which time both legs were over, ant swelling and pain of the left leg per, :l for mor{ than 6 months. An ulcer appeared Vlay 1936. which was treated with a pressure dl ng. Recur. rent ulcers and thrombophlebitis o{ red, whicl~ required pressure dressings, injectio, f the vein. and finally high and low saphenous v igations al the Henry Ford Hospital in 1947. Du periods ot disability, Conrad found relief of l )mfort by standing in a swimming pool In se: ing for a~ explanation for this relief, he made g~v_ use of his intelligence and scientific background. Diagrams ir~ handwriting indicate that he had a good understanding of normal venous physiology and the importance of the venous valves and muscular contraction within their fascial compartment in pumping blood through the deep veins against gravity when the leg is in vertical position. 49 He further reasoned that th{ hydrostatic pressure within the leg veins would b{ equaled by the hydrostatic pressure of the water wher standing in a pool. s° This would provide externa graded compression of both the superficial and dee[ veins of the leg, which could decrease "congestion' (venous blood volume) and provide strong circum. ferential support for the superficial veins so that "the
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elastic support works in unison with the natural muscle pump. ''49 Jobst set out to make an elastic stocking that would duplicate the hydrostatic pressure found in the swimming pool. The stocking would have to be a perfect fit. He accomplished this by making serial circumferenrial measurements of the leg, which were used to make a pattern from which the elastic material could be cut for individualized stockings. He developed a partially elastic "bobinet" woven fabric that had both uniform and predictable stretching and contracting abilities. Graded pressures exerted by the stockings were obtained by progressively reducing the circumference of the stocking from the top of the stocking to the ankle by the percentage necessary. The first stockings were made by hand by Jobst and enabled him to enjoy rapid and continued relief of his own disability. Beninson51 described the early success of the use of pressure gradient stockings in the management of difficult cases of venous ulcers and edema. The positive benefits of graded compression elastic support have been confirmed by several physiologic studies. The velocity of flow in the femoral veins has been studied in normal resting limbs at various graduated external pressures by Lawrence and Kakkar. s2 They found up to 75% increase in deep venous flow with optimal ankle compressions of 18 mm Hg and calf compression of 14 mm Hg with knee-high stockings. Johnson and others have made similar observations. 5a Their studies have objectively demonstrated that properly constructed graded compression stockings increase venous velocity presumably caused by a reduction in circulating venous blood volume and supports the use of these stockings for prophylaxis against thromboembolism. Ambulatory foot venous pressure studies were performed on postphlebitic and normal limbs by O'Donnell and associates, 54 They observed wide swings in amplitude of the pressure tracings during exercise in postphlebitic limbs without stockings with resultant markedly elevated peak pressures. The amplitude of the venous pressure tracings could be normalized with noncustom-made elastic stockings. Homer 5~ performed similar studies on 22 extremities with deep venous valvular insufficiency. They found four patients with small ankles and large calves in which the noncustom-made "graduated pressure" elastic stockings did not have a pressure gradient between their ankle and calf. Stockings were custom-made for them. Pressu;e gradients between the ankle and calf produced by the stockings were then measured for all 22 extremities. They found
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greater decreases in the venous pressure after exercise with stockings on in all but two patients with known deep venous obstruction. Of most significance is that "the greater the compression gradient between the ankle and calf produced by the stocking, the lower the ambulatory venous pressures." Somerville and associates 56 measured ambulatory venous pressures on patients with varicose veins after wearing elastic stockings in which significant pressure gradients between the ankle and the calf were confirmed. The pressures were measured before and 1 and 2 months after wearing the stocking. The stocking was discarded, and then the pressure was measured 1 and 5 months later. The ambulatory venous pressures progressively and significantly fell, and symptoms improved during the 2 months that elastic support was worn and then gradually returned to the pretesting values during the 5 months that no elastic support was used. A significantly positive correlation was found between symptoms and venous ambulatory pressures. The advantage of decreased ambulatory venous pressures for patients with venous insufficiency was emphasized by Shull and associatesS He found that the incidence of ulceration with ambulatory venous pressures greater than 60 mm Hg was 66%, with 40 to 60 mm Hg pressure the incidence was 26%, and with less than 40 mm Hg pressure it was 0. Limb volume, sodium 24 clearance, and calf circumferences have also been used to evaluate the effectiveness of graded compression elastic stockings. Jones and associates s8 measured foot volumes and 24Na clearance studies from the subcutaneous tissue at the ankle before and after exercise pretesting and 3 weeks after wearing elastic stockings. Patients were randomly assigned to wear elastic stockings that exerted ankle compression of 30, 30 to 40, and 40 to 50 mm Hg. All patients wore the three different compression stockings for 3 weeks, with 6 weeks without stockings between the test periods. Normal limbs demonstrated no significant changes in foot volume or 24Na clearance with the use of stockings at rest or after exercise. Limbs with varicose veins demonstrated no significant changes in foot volumes during testing. However, 24Na clearance was significantly improved at rest and almost significantly improved after exercise from using the 30 to 40 mm Hg compression stockings. Postphlebitic limbs demonstrated significant decreases in foot volume and increases in 24Na clearance after the use of the 30 to 40 mm Hg and 40 to 50 mm Hg compression stockings. Pierson, Swallow, and J o h n s o n 59 studied the changes in lower leg volumes and calf circumferences of 30 control subjects and 73 patients with
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s y m p t o m a t i c venous a n d l y m p h a t i c abnormalities w h o w o r e g r a d e d c o m p r e s s i o n elastic stockings that h a d 2 4 m m H g pressure c o m p r e s s i o n at the ankle for 1 week. I n n o r m a l limbs there was significant decrease in v o l u m e . I n patients w i t h s y m p t o m s there was a significant decrease in v o l u m e , circumference, a n d s y m p t o m s w i t h use o f the stockings. These p h y s i o l o g i c studies s u p p o r t the hypothesis t h a t p r o p e r l y fitted g r a d e d c o m p r e s s i o n elastic stockings encase the veins in a s e m i r i g i d elastic envelope. This envelope decreases the v o l u m e o f the superficial v e n o u s system, decreases the d i a m e t e r o f the dilated veins thus r e s t o r i n g valvular c o m p e t e n c e , o p p o s e s the reflux o f b l o o d t h r o u g h i n c o m p e t e n t perforators i n t o the superficial veins, a n d p o s s i b l y enhances c o m p r e s s i o n a n d e m p t y i n g o f d e e p veins d u r i n g calf muscle contraction, s6 These studies also s u p p o r t the logic t h a t C o n r a d J o b s t expressed in explaining the beneficial effects o f h y d r o s t a t i c pressure o n his venous stasis ulcers, w h i c h l e d to the d e v e l o p m e n t o f g r a d e d c o m p r e s s i o n elastic stockings. I agree w i t h the s t a t e m e n t o f Dr. J o h n Bergan t h a t " T h e single advance t h a t has h a d the m o s t i m p a c t o n the t r e a t m e n t o f v e n o u s stasis disease has been the d e v e l o p m e n t o f v e n o u s pressure g r a d i e n t s u p p o r t . ''49 REFERENCES
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Submitted March 2, 1994; accepted March 9, 1994.